510(k) · Cleared
ClearedEndovascular Dilator and Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Apr 6, 2021 as substantially equivalent to K183036 (Cook Incorporated, 2018) after a 26-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 6, 2021
- Review
- 26 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961904 (1996). 5 ancestors in all, the oldest K801113 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 2 generations backK990808 PBN DilatorsMedical Device Technologies, Inc. · 1999
- 1 generation backK183036 Dilator SetsCook Incorporated · 2018 · Recalled
- This deviceK210734 Endovascular Dilator and SetsCook Incorporated · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −2 | K990808 | PBN Dilators | Medical Device Technologies, Inc. | 1999 | — |
| −1 | K183036 | Dilator Sets | Cook Incorporated | 2018 | 3 |
| 0 (this device) | K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183036 | Dilator SetsSummary page 5…vascular Dilator and Sets. Since there is no design change to the device subject of this submission, the testing that was provided for the predicate device in submission K183036 remains to support this submission. No additional testing or design control activities or risk assessment are required to support… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210734: Endovascular Dilator and Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210734
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026